FindTrial
Sign In

Efficacy and Safety of Ledipasvir/Sofosbuvir Fixed-Dose Combination and Sofosbuvir + Ribavirin for Subjects With Chronic Hepatitis C Virus (HCV) and Inherited Bleeding Disorders

A Phase 2b, Multicenter, Open-Label Study to Investigate the Efficacy and Safety of Sofosbuvir/Ledipasvir Fixed-Dose Combination and Sofosbuvir + Ribavirin for Subjects With Chronic Hepatitis C Virus (HCV) and Inherited Bleeding Disorders

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02120300
Enrollment
122
Registered
2014-04-22
Start date
2014-04-30
Completion date
2015-08-31
Last updated
2016-12-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic HCV Infection

Brief summary

The primary objectives of this study are to evaluate the antiviral efficacy, safety, and tolerability of treatment with ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC) in participants with genotypes 1 and 4 hepatitis C virus (HCV) infection and sofosbuvir (SOF) plus ribavirin (RBV) in participants with genotypes 2 and 3 HCV infection. Participants with an inherited bleeding disorder and chronic HCV infection (either monoinfected or HIV-1/HCV coinfected) will be enrolled.

Interventions

DRUGLDV/SOF

90/400 mg FDC tablet administered orally

DRUGSOF

400 mg tablet administered orally once daily

DRUGRBV

Ribavirin (RBV) tablets administered orally in a divided daily dose according to package insert weight-based dosing recommendations (\< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg)

Sponsors

Gilead Sciences
Lead SponsorINDUSTRY

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Hemophilia A, B or C, or Von Willebrand's disease * Chronic genotype 1, 2, 3 or 4 HCV infection * HCV RNA ≥ 1000 IU/mL at screening * Use of protocol specified method(s) of contraception if female of childbearing potential or sexually active male * Screening laboratory values within defined thresholds * For HIV-1/HCV co-infected individuals: * Suppressed HIV-1 RNA on an antiretroviral (ARV) regimen for at least 6 months prior to screening * Stable protocol-approved ARV regimen for \> 8 weeks prior to screening * CD4 T-cell count \> 200 cells/mm\^3 at screening

Exclusion criteria

* Clinically-significant illness (other than HCV, inherited bleeding disorder or HIV-1) or any other major medical disorder that may interfere with subject treatment, assessment or compliance with the protocol * Current or prior history of any of the following: * Hepatic decompensation * Chronic liver disease of a non-HCV etiology * Hepatocellular carcinoma (HCC) * Infection with hepatitis B virus (HBV) * Pregnant or nursing female * Prior treatment with inhibitors of nonstructural protein 5A (NS5A) or the NS5B polymerase * Chronic use of systemically administered immunosuppressive agents * For HIV-1/HCV co-infected individuals: * Opportunistic infection within 6 months prior to screening * Active, serious infection (other than HIV-1 or HCV) requiring parental antibiotics, antivirals or antifungals within 30 days prior to baseline

Design outcomes

Primary

MeasureTime frameDescription
Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)Posttreatment Week 12SVR12 was defined as HCV RNA \< the lower limit of quantitation (LLOQ; ie, 15 IU/mL) at 12 weeks after stopping study treatment.
Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse EventUp to 24 weeks—

Secondary

MeasureTime frameDescription
Change From Baseline in HCV RNA at Weeks 1, 2, 4, 8, 12, 16, 20, and 24Baseline; Weeks 1, 2, 4, 8, 12, 16, 20, and 24—
Percentage of Participants With Virologic FailureUp to Posttreatment Week 24Virologic failure was defined as: * On-treatment virologic failure: * Breakthrough (confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA \< LLOQ while on treatment), or * Rebound (confirmed \> 1 log10 IU/mL increase in HCV RNA from nadir while on treatment), or * Non-response (HCV RNA persistently ≥ LLOQ through 8 weeks of treatment) * Virologic relapse: * Confirmed HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA \< LLOQ at last on-treatment visit.
Percentage of Participants With SVR at 4 Weeks After Discontinuation of Therapy (SVR4)Posttreatment Week 4SVR4 was defined as HCV RNA \< LLOQ at 4 weeks after stopping study treatment.
Change From Baseline in Serum Creatinine at the End of Treatment and at Posttreatment Week 12 (HIV-1/HCV Co-infected Participants Only)Baseline; Weeks 12, 24, and Posttreatment Week 12—
Percentage of Participants That Maintain HIV-1 RNA < 50 Copies/mL at Weeks 4, 8, 12, 16, 20, and 24 (HIV-1/HCV Co-infected Participants Only)Weeks 4, 8, 12, 16, 20, and 24—
Percentage of Participants With HCV RNA < LLOQ at Weeks 1, 2, 4, 8, 12, 16, 20, and 24Weeks 1, 2, 4, 8, 12, 16, 20, and 24—

Countries

United States

Participant flow

Recruitment details

Participants were enrolled at study sites in the United States. The first participant was screened on 10 April 2014. The last study visit occurred on 17 August 2015.

Pre-assignment details

147 participants were screened.

Participants by arm

ArmCount
LDV/SOF 12 Weeks GT1 or GT4
Ledipasvir/sofosbuvir (LDV/SOF) (90/400 mg) fixed-dose combination (FDC) tablet once daily for 12 weeks (genotype 1 or 4)
99
LDV/SOF 24 Weeks GT1 (TE)
LDV/SOF (90/400 mg) FDC tablet once daily for 24 weeks (treatment-experienced \[TE\] participants with genotype 1 HCV infection and cirrhosis)
5
SOF+RBV 12 Weeks GT2
Sofosbuvir (SOF) 400 mg tablet once daily + ribavirin (RBV) tablets (1000 or 1200 mg daily based on weight) for 12 weeks (genotype 2)
10
SOF+RBV 24 Weeks GT3
SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 24 weeks (genotype 3)
6
Total120

Withdrawals & dropouts

PeriodReasonFG000FG001FG002FG003
Overall StudyEnrolled but Never Treated2000
Overall StudyLack of Efficacy0001
Overall StudyLost to Follow-up1000

Baseline characteristics

CharacteristicLDV/SOF 12 Weeks GT1 or GT4LDV/SOF 24 Weeks GT1 (TE)SOF+RBV 12 Weeks GT2SOF+RBV 24 Weeks GT3Total
Age, Continuous44 Years
STANDARD_DEVIATION 11.1
49 Years
STANDARD_DEVIATION 11.1
48 Years
STANDARD_DEVIATION 13.8
47 Years
STANDARD_DEVIATION 6.7
45 Years
STANDARD_DEVIATION 11.1
Cirrhosis Status
No
71 participants0 participants8 participants4 participants83 participants
Cirrhosis Status
Yes
28 participants5 participants2 participants2 participants37 participants
Ethnicity (NIH/OMB)
Hispanic or Latino
4 Participants0 Participants1 Participants0 Participants5 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
95 Participants5 Participants9 Participants6 Participants115 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants0 Participants0 Participants
HCV Genotype
Genotype 1
98 participants5 participants0 participants0 participants103 participants
HCV Genotype
Genotype 2
0 participants0 participants10 participants0 participants10 participants
HCV Genotype
Genotype 3
0 participants0 participants0 participants6 participants6 participants
HCV Genotype
Genotype 4
1 participants0 participants0 participants0 participants1 participants
HCV RNA6.2 log10 IU/mL
STANDARD_DEVIATION 0.67
6.0 log10 IU/mL
STANDARD_DEVIATION 0.85
6.2 log10 IU/mL
STANDARD_DEVIATION 1
6.6 log10 IU/mL
STANDARD_DEVIATION 0.8
6.2 log10 IU/mL
STANDARD_DEVIATION 0.71
HCV RNA Category
< 800,000 IU/mL
23 participants2 participants2 participants1 participants28 participants
HCV RNA Category
≥ 800,000 IU/mL
76 participants3 participants8 participants5 participants92 participants
HIV Status
Negative
80 participants5 participants6 participants3 participants94 participants
HIV Status
Positive
19 participants0 participants4 participants3 participants26 participants
IL28b Status
CC
22 participants2 participants7 participants5 participants36 participants
IL28b Status
CT
60 participants1 participants3 participants1 participants65 participants
IL28b Status
TT
17 participants2 participants0 participants0 participants19 participants
Race/Ethnicity, Customized
Asian
4 participants0 participants1 participants1 participants6 participants
Race/Ethnicity, Customized
Black or African American
18 participants1 participants1 participants0 participants20 participants
Race/Ethnicity, Customized
Other
2 participants0 participants0 participants0 participants2 participants
Race/Ethnicity, Customized
White
75 participants4 participants8 participants5 participants92 participants
Sex: Female, Male
Female
6 Participants0 Participants1 Participants0 Participants7 Participants
Sex: Female, Male
Male
93 Participants5 Participants9 Participants6 Participants113 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
EG003
affected / at risk
deaths
Total, all-cause mortality
— / —— / —— / —— / —
other
Total, other adverse events
54 / 993 / 58 / 104 / 6
serious
Total, serious adverse events
5 / 990 / 50 / 101 / 6

Outcome results

Primary

Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event

Time frame: Up to 24 weeks

Population: Safety Analysis Set

ArmMeasureValue (NUMBER)
LDV/SOF 12 Weeks GT1 or GT4Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event0 percentage of participants
LDV/SOF 24 Weeks GT1 (TE)Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event0 percentage of participants
SOF+RBV 12 Weeks GT2Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event0 percentage of participants
SOF+RBV 24 Weeks GT3Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event0 percentage of participants
Primary

Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)

SVR12 was defined as HCV RNA \< the lower limit of quantitation (LLOQ; ie, 15 IU/mL) at 12 weeks after stopping study treatment.

Time frame: Posttreatment Week 12

Population: Full Analysis Set: participants enrolled into the study and received at least 1 dose of study drug.

ArmMeasureValue (NUMBER)
LDV/SOF 12 Weeks GT1 or GT4Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)99.0 percentage of participants
LDV/SOF 24 Weeks GT1 (TE)Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)100.0 percentage of participants
SOF+RBV 12 Weeks GT2Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)100.0 percentage of participants
SOF+RBV 24 Weeks GT3Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)83.3 percentage of participants
Secondary

Change From Baseline in HCV RNA at Weeks 1, 2, 4, 8, 12, 16, 20, and 24

Time frame: Baseline; Weeks 1, 2, 4, 8, 12, 16, 20, and 24

Population: Participants in the Full Analysis Set with available data were analyzed.

ArmMeasureGroupValue (MEAN)Dispersion
LDV/SOF 12 Weeks GT1 or GT4Change From Baseline in HCV RNA at Weeks 1, 2, 4, 8, 12, 16, 20, and 24Week 16NA log10 IU/mL—
LDV/SOF 12 Weeks GT1 or GT4Change From Baseline in HCV RNA at Weeks 1, 2, 4, 8, 12, 16, 20, and 24Week 24NA log10 IU/mL—
LDV/SOF 12 Weeks GT1 or GT4Change From Baseline in HCV RNA at Weeks 1, 2, 4, 8, 12, 16, 20, and 24Baseline6.21 log10 IU/mLStandard Deviation 0.673
LDV/SOF 12 Weeks GT1 or GT4Change From Baseline in HCV RNA at Weeks 1, 2, 4, 8, 12, 16, 20, and 24Week 2 (LDV/SOF 24 Week: n=4)-4.87 log10 IU/mLStandard Deviation 0.642
LDV/SOF 12 Weeks GT1 or GT4Change From Baseline in HCV RNA at Weeks 1, 2, 4, 8, 12, 16, 20, and 24Week 20NA log10 IU/mL—
LDV/SOF 12 Weeks GT1 or GT4Change From Baseline in HCV RNA at Weeks 1, 2, 4, 8, 12, 16, 20, and 24Week 4-5.05 log10 IU/mLStandard Deviation 0.662
LDV/SOF 12 Weeks GT1 or GT4Change From Baseline in HCV RNA at Weeks 1, 2, 4, 8, 12, 16, 20, and 24Week 8-5.06 log10 IU/mLStandard Deviation 0.673
LDV/SOF 12 Weeks GT1 or GT4Change From Baseline in HCV RNA at Weeks 1, 2, 4, 8, 12, 16, 20, and 24Week 12 (LDV/SOF 12 Weeks: n= 98)-5.06 log10 IU/mLStandard Deviation 0.675
LDV/SOF 12 Weeks GT1 or GT4Change From Baseline in HCV RNA at Weeks 1, 2, 4, 8, 12, 16, 20, and 24Week 1 (LDV/SOF 12 Weeks: n= 98)-4.41 log10 IU/mLStandard Deviation 0.58
LDV/SOF 24 Weeks GT1 (TE)Change From Baseline in HCV RNA at Weeks 1, 2, 4, 8, 12, 16, 20, and 24Baseline6.02 log10 IU/mLStandard Deviation 0.847
LDV/SOF 24 Weeks GT1 (TE)Change From Baseline in HCV RNA at Weeks 1, 2, 4, 8, 12, 16, 20, and 24Week 16-4.87 log10 IU/mLStandard Deviation 0.847
LDV/SOF 24 Weeks GT1 (TE)Change From Baseline in HCV RNA at Weeks 1, 2, 4, 8, 12, 16, 20, and 24Week 20-4.87 log10 IU/mLStandard Deviation 0.847
LDV/SOF 24 Weeks GT1 (TE)Change From Baseline in HCV RNA at Weeks 1, 2, 4, 8, 12, 16, 20, and 24Week 4-4.87 log10 IU/mLStandard Deviation 0.847
LDV/SOF 24 Weeks GT1 (TE)Change From Baseline in HCV RNA at Weeks 1, 2, 4, 8, 12, 16, 20, and 24Week 1 (LDV/SOF 12 Weeks: n= 98)-4.32 log10 IU/mLStandard Deviation 0.815
LDV/SOF 24 Weeks GT1 (TE)Change From Baseline in HCV RNA at Weeks 1, 2, 4, 8, 12, 16, 20, and 24Week 12 (LDV/SOF 12 Weeks: n= 98)-4.87 log10 IU/mLStandard Deviation 0.847
LDV/SOF 24 Weeks GT1 (TE)Change From Baseline in HCV RNA at Weeks 1, 2, 4, 8, 12, 16, 20, and 24Week 24-4.87 log10 IU/mLStandard Deviation 0.847
LDV/SOF 24 Weeks GT1 (TE)Change From Baseline in HCV RNA at Weeks 1, 2, 4, 8, 12, 16, 20, and 24Week 2 (LDV/SOF 24 Week: n=4)-4.65 log10 IU/mLStandard Deviation 0.967
LDV/SOF 24 Weeks GT1 (TE)Change From Baseline in HCV RNA at Weeks 1, 2, 4, 8, 12, 16, 20, and 24Week 8-4.87 log10 IU/mLStandard Deviation 0.847
SOF+RBV 12 Weeks GT2Change From Baseline in HCV RNA at Weeks 1, 2, 4, 8, 12, 16, 20, and 24Baseline6.20 log10 IU/mLStandard Deviation 1.002
SOF+RBV 12 Weeks GT2Change From Baseline in HCV RNA at Weeks 1, 2, 4, 8, 12, 16, 20, and 24Week 8-5.05 log10 IU/mLStandard Deviation 1.002
SOF+RBV 12 Weeks GT2Change From Baseline in HCV RNA at Weeks 1, 2, 4, 8, 12, 16, 20, and 24Week 2 (LDV/SOF 24 Week: n=4)-5.01 log10 IU/mLStandard Deviation 0.965
SOF+RBV 12 Weeks GT2Change From Baseline in HCV RNA at Weeks 1, 2, 4, 8, 12, 16, 20, and 24Week 16NA log10 IU/mL—
SOF+RBV 12 Weeks GT2Change From Baseline in HCV RNA at Weeks 1, 2, 4, 8, 12, 16, 20, and 24Week 12 (LDV/SOF 12 Weeks: n= 98)-5.05 log10 IU/mLStandard Deviation 1.002
SOF+RBV 12 Weeks GT2Change From Baseline in HCV RNA at Weeks 1, 2, 4, 8, 12, 16, 20, and 24Week 4-5.05 log10 IU/mLStandard Deviation 1.002
SOF+RBV 12 Weeks GT2Change From Baseline in HCV RNA at Weeks 1, 2, 4, 8, 12, 16, 20, and 24Week 1 (LDV/SOF 12 Weeks: n= 98)-4.39 log10 IU/mLStandard Deviation 0.633
SOF+RBV 12 Weeks GT2Change From Baseline in HCV RNA at Weeks 1, 2, 4, 8, 12, 16, 20, and 24Week 20NA log10 IU/mL—
SOF+RBV 12 Weeks GT2Change From Baseline in HCV RNA at Weeks 1, 2, 4, 8, 12, 16, 20, and 24Week 24NA log10 IU/mL—
SOF+RBV 24 Weeks GT3Change From Baseline in HCV RNA at Weeks 1, 2, 4, 8, 12, 16, 20, and 24Week 24-5.45 log10 IU/mLStandard Deviation 0.803
SOF+RBV 24 Weeks GT3Change From Baseline in HCV RNA at Weeks 1, 2, 4, 8, 12, 16, 20, and 24Week 16-5.45 log10 IU/mLStandard Deviation 0.803
SOF+RBV 24 Weeks GT3Change From Baseline in HCV RNA at Weeks 1, 2, 4, 8, 12, 16, 20, and 24Baseline6.6 log10 IU/mLStandard Deviation 0.803
SOF+RBV 24 Weeks GT3Change From Baseline in HCV RNA at Weeks 1, 2, 4, 8, 12, 16, 20, and 24Week 1 (LDV/SOF 12 Weeks: n= 98)-3.95 log10 IU/mLStandard Deviation 0.473
SOF+RBV 24 Weeks GT3Change From Baseline in HCV RNA at Weeks 1, 2, 4, 8, 12, 16, 20, and 24Week 2 (LDV/SOF 24 Week: n=4)-4.76 log10 IU/mLStandard Deviation 0.797
SOF+RBV 24 Weeks GT3Change From Baseline in HCV RNA at Weeks 1, 2, 4, 8, 12, 16, 20, and 24Week 4-5.26 log10 IU/mLStandard Deviation 0.786
SOF+RBV 24 Weeks GT3Change From Baseline in HCV RNA at Weeks 1, 2, 4, 8, 12, 16, 20, and 24Week 8-5.45 log10 IU/mLStandard Deviation 0.803
SOF+RBV 24 Weeks GT3Change From Baseline in HCV RNA at Weeks 1, 2, 4, 8, 12, 16, 20, and 24Week 12 (LDV/SOF 12 Weeks: n= 98)-5.45 log10 IU/mLStandard Deviation 0.803
SOF+RBV 24 Weeks GT3Change From Baseline in HCV RNA at Weeks 1, 2, 4, 8, 12, 16, 20, and 24Week 20-5.45 log10 IU/mLStandard Deviation 0.803
Secondary

Change From Baseline in Serum Creatinine at the End of Treatment and at Posttreatment Week 12 (HIV-1/HCV Co-infected Participants Only)

Time frame: Baseline; Weeks 12, 24, and Posttreatment Week 12

Population: Participants coinfected with HIV-1 and HCV in the Safety Analysis Set with available data were analyzed.

ArmMeasureGroupValue (MEAN)Dispersion
LDV/SOF 12 Weeks GT1 or GT4Change From Baseline in Serum Creatinine at the End of Treatment and at Posttreatment Week 12 (HIV-1/HCV Co-infected Participants Only)Baseline0.94 mg/dLStandard Deviation 0.197
LDV/SOF 12 Weeks GT1 or GT4Change From Baseline in Serum Creatinine at the End of Treatment and at Posttreatment Week 12 (HIV-1/HCV Co-infected Participants Only)Week 24NA mg/dL—
LDV/SOF 12 Weeks GT1 or GT4Change From Baseline in Serum Creatinine at the End of Treatment and at Posttreatment Week 12 (HIV-1/HCV Co-infected Participants Only)Week 120.04 mg/dLStandard Deviation 0.079
LDV/SOF 12 Weeks GT1 or GT4Change From Baseline in Serum Creatinine at the End of Treatment and at Posttreatment Week 12 (HIV-1/HCV Co-infected Participants Only)Posttreatment Week12-0.01 mg/dLStandard Deviation 0.113
LDV/SOF 24 Weeks GT1 (TE)Change From Baseline in Serum Creatinine at the End of Treatment and at Posttreatment Week 12 (HIV-1/HCV Co-infected Participants Only)Baseline1.01 mg/dLStandard Deviation 0.118
LDV/SOF 24 Weeks GT1 (TE)Change From Baseline in Serum Creatinine at the End of Treatment and at Posttreatment Week 12 (HIV-1/HCV Co-infected Participants Only)Posttreatment Week12-0.08 mg/dLStandard Deviation 0.015
LDV/SOF 24 Weeks GT1 (TE)Change From Baseline in Serum Creatinine at the End of Treatment and at Posttreatment Week 12 (HIV-1/HCV Co-infected Participants Only)Week 24NA mg/dL—
LDV/SOF 24 Weeks GT1 (TE)Change From Baseline in Serum Creatinine at the End of Treatment and at Posttreatment Week 12 (HIV-1/HCV Co-infected Participants Only)Week 12-0.03 mg/dLStandard Deviation 0.095
SOF+RBV 12 Weeks GT2Change From Baseline in Serum Creatinine at the End of Treatment and at Posttreatment Week 12 (HIV-1/HCV Co-infected Participants Only)Posttreatment Week12-0.02 mg/dLStandard Deviation 0.081
SOF+RBV 12 Weeks GT2Change From Baseline in Serum Creatinine at the End of Treatment and at Posttreatment Week 12 (HIV-1/HCV Co-infected Participants Only)Week 24-0.08 mg/dLStandard Deviation 0.069
SOF+RBV 12 Weeks GT2Change From Baseline in Serum Creatinine at the End of Treatment and at Posttreatment Week 12 (HIV-1/HCV Co-infected Participants Only)Week 12-0.03 mg/dLStandard Deviation 0.093
SOF+RBV 12 Weeks GT2Change From Baseline in Serum Creatinine at the End of Treatment and at Posttreatment Week 12 (HIV-1/HCV Co-infected Participants Only)Baseline0.94 mg/dLStandard Deviation 0.086
Secondary

Percentage of Participants That Maintain HIV-1 RNA < 50 Copies/mL at Weeks 4, 8, 12, 16, 20, and 24 (HIV-1/HCV Co-infected Participants Only)

Time frame: Weeks 4, 8, 12, 16, 20, and 24

Population: Only the participants coinfected with HIV-1 and HCV in the Safety Analysis Set with available data were analyzed.

ArmMeasureGroupValue (NUMBER)
LDV/SOF 12 Weeks GT1 or GT4Percentage of Participants That Maintain HIV-1 RNA < 50 Copies/mL at Weeks 4, 8, 12, 16, 20, and 24 (HIV-1/HCV Co-infected Participants Only)Week 12100 percentage of participants
LDV/SOF 12 Weeks GT1 or GT4Percentage of Participants That Maintain HIV-1 RNA < 50 Copies/mL at Weeks 4, 8, 12, 16, 20, and 24 (HIV-1/HCV Co-infected Participants Only)Week 8100 percentage of participants
LDV/SOF 12 Weeks GT1 or GT4Percentage of Participants That Maintain HIV-1 RNA < 50 Copies/mL at Weeks 4, 8, 12, 16, 20, and 24 (HIV-1/HCV Co-infected Participants Only)Week 16NA percentage of participants
LDV/SOF 12 Weeks GT1 or GT4Percentage of Participants That Maintain HIV-1 RNA < 50 Copies/mL at Weeks 4, 8, 12, 16, 20, and 24 (HIV-1/HCV Co-infected Participants Only)Week 24NA percentage of participants
LDV/SOF 12 Weeks GT1 or GT4Percentage of Participants That Maintain HIV-1 RNA < 50 Copies/mL at Weeks 4, 8, 12, 16, 20, and 24 (HIV-1/HCV Co-infected Participants Only)Week 20NA percentage of participants
LDV/SOF 12 Weeks GT1 or GT4Percentage of Participants That Maintain HIV-1 RNA < 50 Copies/mL at Weeks 4, 8, 12, 16, 20, and 24 (HIV-1/HCV Co-infected Participants Only)Week 4100 percentage of participants
LDV/SOF 24 Weeks GT1 (TE)Percentage of Participants That Maintain HIV-1 RNA < 50 Copies/mL at Weeks 4, 8, 12, 16, 20, and 24 (HIV-1/HCV Co-infected Participants Only)Week 4100 percentage of participants
LDV/SOF 24 Weeks GT1 (TE)Percentage of Participants That Maintain HIV-1 RNA < 50 Copies/mL at Weeks 4, 8, 12, 16, 20, and 24 (HIV-1/HCV Co-infected Participants Only)Week 8100 percentage of participants
LDV/SOF 24 Weeks GT1 (TE)Percentage of Participants That Maintain HIV-1 RNA < 50 Copies/mL at Weeks 4, 8, 12, 16, 20, and 24 (HIV-1/HCV Co-infected Participants Only)Week 12100 percentage of participants
LDV/SOF 24 Weeks GT1 (TE)Percentage of Participants That Maintain HIV-1 RNA < 50 Copies/mL at Weeks 4, 8, 12, 16, 20, and 24 (HIV-1/HCV Co-infected Participants Only)Week 16NA percentage of participants
LDV/SOF 24 Weeks GT1 (TE)Percentage of Participants That Maintain HIV-1 RNA < 50 Copies/mL at Weeks 4, 8, 12, 16, 20, and 24 (HIV-1/HCV Co-infected Participants Only)Week 20NA percentage of participants
LDV/SOF 24 Weeks GT1 (TE)Percentage of Participants That Maintain HIV-1 RNA < 50 Copies/mL at Weeks 4, 8, 12, 16, 20, and 24 (HIV-1/HCV Co-infected Participants Only)Week 24NA percentage of participants
SOF+RBV 12 Weeks GT2Percentage of Participants That Maintain HIV-1 RNA < 50 Copies/mL at Weeks 4, 8, 12, 16, 20, and 24 (HIV-1/HCV Co-infected Participants Only)Week 8100 percentage of participants
SOF+RBV 12 Weeks GT2Percentage of Participants That Maintain HIV-1 RNA < 50 Copies/mL at Weeks 4, 8, 12, 16, 20, and 24 (HIV-1/HCV Co-infected Participants Only)Week 2466.7 percentage of participants
SOF+RBV 12 Weeks GT2Percentage of Participants That Maintain HIV-1 RNA < 50 Copies/mL at Weeks 4, 8, 12, 16, 20, and 24 (HIV-1/HCV Co-infected Participants Only)Week 20100 percentage of participants
SOF+RBV 12 Weeks GT2Percentage of Participants That Maintain HIV-1 RNA < 50 Copies/mL at Weeks 4, 8, 12, 16, 20, and 24 (HIV-1/HCV Co-infected Participants Only)Week 12100 percentage of participants
SOF+RBV 12 Weeks GT2Percentage of Participants That Maintain HIV-1 RNA < 50 Copies/mL at Weeks 4, 8, 12, 16, 20, and 24 (HIV-1/HCV Co-infected Participants Only)Week 4100 percentage of participants
SOF+RBV 12 Weeks GT2Percentage of Participants That Maintain HIV-1 RNA < 50 Copies/mL at Weeks 4, 8, 12, 16, 20, and 24 (HIV-1/HCV Co-infected Participants Only)Week 16100 percentage of participants
Secondary

Percentage of Participants With HCV RNA < LLOQ at Weeks 1, 2, 4, 8, 12, 16, 20, and 24

Time frame: Weeks 1, 2, 4, 8, 12, 16, 20, and 24

Population: Participants in the Full Analysis Set with available data were analyzed.

ArmMeasureGroupValue (NUMBER)
LDV/SOF 12 Weeks GT1 or GT4Percentage of Participants With HCV RNA < LLOQ at Weeks 1, 2, 4, 8, 12, 16, 20, and 24Week 128.3 percentage of participants
LDV/SOF 12 Weeks GT1 or GT4Percentage of Participants With HCV RNA < LLOQ at Weeks 1, 2, 4, 8, 12, 16, 20, and 24Week 268.7 percentage of participants
LDV/SOF 12 Weeks GT1 or GT4Percentage of Participants With HCV RNA < LLOQ at Weeks 1, 2, 4, 8, 12, 16, 20, and 24Week 1299.0 percentage of participants
LDV/SOF 12 Weeks GT1 or GT4Percentage of Participants With HCV RNA < LLOQ at Weeks 1, 2, 4, 8, 12, 16, 20, and 24Week 8100.0 percentage of participants
LDV/SOF 12 Weeks GT1 or GT4Percentage of Participants With HCV RNA < LLOQ at Weeks 1, 2, 4, 8, 12, 16, 20, and 24Week 20NA percentage of participants
LDV/SOF 12 Weeks GT1 or GT4Percentage of Participants With HCV RNA < LLOQ at Weeks 1, 2, 4, 8, 12, 16, 20, and 24Week 494.9 percentage of participants
LDV/SOF 12 Weeks GT1 or GT4Percentage of Participants With HCV RNA < LLOQ at Weeks 1, 2, 4, 8, 12, 16, 20, and 24Week 16NA percentage of participants
LDV/SOF 12 Weeks GT1 or GT4Percentage of Participants With HCV RNA < LLOQ at Weeks 1, 2, 4, 8, 12, 16, 20, and 24Week 24NA percentage of participants
LDV/SOF 24 Weeks GT1 (TE)Percentage of Participants With HCV RNA < LLOQ at Weeks 1, 2, 4, 8, 12, 16, 20, and 24Week 20100.0 percentage of participants
LDV/SOF 24 Weeks GT1 (TE)Percentage of Participants With HCV RNA < LLOQ at Weeks 1, 2, 4, 8, 12, 16, 20, and 24Week 8100.0 percentage of participants
LDV/SOF 24 Weeks GT1 (TE)Percentage of Participants With HCV RNA < LLOQ at Weeks 1, 2, 4, 8, 12, 16, 20, and 24Week 12100.0 percentage of participants
LDV/SOF 24 Weeks GT1 (TE)Percentage of Participants With HCV RNA < LLOQ at Weeks 1, 2, 4, 8, 12, 16, 20, and 24Week 120.0 percentage of participants
LDV/SOF 24 Weeks GT1 (TE)Percentage of Participants With HCV RNA < LLOQ at Weeks 1, 2, 4, 8, 12, 16, 20, and 24Week 24100.0 percentage of participants
LDV/SOF 24 Weeks GT1 (TE)Percentage of Participants With HCV RNA < LLOQ at Weeks 1, 2, 4, 8, 12, 16, 20, and 24Week 240.0 percentage of participants
LDV/SOF 24 Weeks GT1 (TE)Percentage of Participants With HCV RNA < LLOQ at Weeks 1, 2, 4, 8, 12, 16, 20, and 24Week 16100.0 percentage of participants
LDV/SOF 24 Weeks GT1 (TE)Percentage of Participants With HCV RNA < LLOQ at Weeks 1, 2, 4, 8, 12, 16, 20, and 24Week 4100.0 percentage of participants
SOF+RBV 12 Weeks GT2Percentage of Participants With HCV RNA < LLOQ at Weeks 1, 2, 4, 8, 12, 16, 20, and 24Week 12100.0 percentage of participants
SOF+RBV 12 Weeks GT2Percentage of Participants With HCV RNA < LLOQ at Weeks 1, 2, 4, 8, 12, 16, 20, and 24Week 16NA percentage of participants
SOF+RBV 12 Weeks GT2Percentage of Participants With HCV RNA < LLOQ at Weeks 1, 2, 4, 8, 12, 16, 20, and 24Week 120.0 percentage of participants
SOF+RBV 12 Weeks GT2Percentage of Participants With HCV RNA < LLOQ at Weeks 1, 2, 4, 8, 12, 16, 20, and 24Week 20NA percentage of participants
SOF+RBV 12 Weeks GT2Percentage of Participants With HCV RNA < LLOQ at Weeks 1, 2, 4, 8, 12, 16, 20, and 24Week 270.0 percentage of participants
SOF+RBV 12 Weeks GT2Percentage of Participants With HCV RNA < LLOQ at Weeks 1, 2, 4, 8, 12, 16, 20, and 24Week 24NA percentage of participants
SOF+RBV 12 Weeks GT2Percentage of Participants With HCV RNA < LLOQ at Weeks 1, 2, 4, 8, 12, 16, 20, and 24Week 4100.0 percentage of participants
SOF+RBV 12 Weeks GT2Percentage of Participants With HCV RNA < LLOQ at Weeks 1, 2, 4, 8, 12, 16, 20, and 24Week 8100.0 percentage of participants
SOF+RBV 24 Weeks GT3Percentage of Participants With HCV RNA < LLOQ at Weeks 1, 2, 4, 8, 12, 16, 20, and 24Week 466.7 percentage of participants
SOF+RBV 24 Weeks GT3Percentage of Participants With HCV RNA < LLOQ at Weeks 1, 2, 4, 8, 12, 16, 20, and 24Week 24100.0 percentage of participants
SOF+RBV 24 Weeks GT3Percentage of Participants With HCV RNA < LLOQ at Weeks 1, 2, 4, 8, 12, 16, 20, and 24Week 116.7 percentage of participants
SOF+RBV 24 Weeks GT3Percentage of Participants With HCV RNA < LLOQ at Weeks 1, 2, 4, 8, 12, 16, 20, and 24Week 233.3 percentage of participants
SOF+RBV 24 Weeks GT3Percentage of Participants With HCV RNA < LLOQ at Weeks 1, 2, 4, 8, 12, 16, 20, and 24Week 20100.0 percentage of participants
SOF+RBV 24 Weeks GT3Percentage of Participants With HCV RNA < LLOQ at Weeks 1, 2, 4, 8, 12, 16, 20, and 24Week 8100.0 percentage of participants
SOF+RBV 24 Weeks GT3Percentage of Participants With HCV RNA < LLOQ at Weeks 1, 2, 4, 8, 12, 16, 20, and 24Week 12100.0 percentage of participants
SOF+RBV 24 Weeks GT3Percentage of Participants With HCV RNA < LLOQ at Weeks 1, 2, 4, 8, 12, 16, 20, and 24Week 16100.0 percentage of participants
Secondary

Percentage of Participants With SVR at 4 Weeks After Discontinuation of Therapy (SVR4)

SVR4 was defined as HCV RNA \< LLOQ at 4 weeks after stopping study treatment.

Time frame: Posttreatment Week 4

Population: Full Analysis Set

ArmMeasureValue (NUMBER)
LDV/SOF 12 Weeks GT1 or GT4Percentage of Participants With SVR at 4 Weeks After Discontinuation of Therapy (SVR4)99.0 percentage of participants
LDV/SOF 24 Weeks GT1 (TE)Percentage of Participants With SVR at 4 Weeks After Discontinuation of Therapy (SVR4)100.0 percentage of participants
SOF+RBV 12 Weeks GT2Percentage of Participants With SVR at 4 Weeks After Discontinuation of Therapy (SVR4)100.0 percentage of participants
SOF+RBV 24 Weeks GT3Percentage of Participants With SVR at 4 Weeks After Discontinuation of Therapy (SVR4)83.3 percentage of participants
Secondary

Percentage of Participants With Virologic Failure

Virologic failure was defined as: * On-treatment virologic failure: * Breakthrough (confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA \< LLOQ while on treatment), or * Rebound (confirmed \> 1 log10 IU/mL increase in HCV RNA from nadir while on treatment), or * Non-response (HCV RNA persistently ≥ LLOQ through 8 weeks of treatment) * Virologic relapse: * Confirmed HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA \< LLOQ at last on-treatment visit.

Time frame: Up to Posttreatment Week 24

Population: Full Analysis Set

ArmMeasureValue (NUMBER)
LDV/SOF 12 Weeks GT1 or GT4Percentage of Participants With Virologic Failure0 percentage of participants
LDV/SOF 24 Weeks GT1 (TE)Percentage of Participants With Virologic Failure0 percentage of participants
SOF+RBV 12 Weeks GT2Percentage of Participants With Virologic Failure0 percentage of participants
SOF+RBV 24 Weeks GT3Percentage of Participants With Virologic Failure16.7 percentage of participants

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026